Combined Basal-bolus Insulin and Post-exercise Carbohydrate Feeding Strategy in T1DM
Not Applicable
Completed
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Drug: Basal insulin dose
- Registration Number
- NCT02204839
- Lead Sponsor
- Northumbria University
- Brief Summary
The investigators hypothesise that reducing basal insulin dose (Glargine, Lantus, Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk), whilst employing current carbohydrate feeding and rapid-acting insulin dose recommendations will protect patients with type 1 diabetes from early- and late-onset hypoglycaemia following evening time exercise.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 10
Inclusion Criteria
- Aged between 18-50 years old (male or female).
- Free from any diabetes related complications (apart from mild background diabetic retinopathy).
- HbA1c <8.5%.
- Not taking any prescribed medication other than insulin, and treated with a stable insulin regimen composed of a combination of slow/long acting insulin (glargine or detemir) and fast-acting insulin analogues (lispro or aspart), for a minimum of 6 months before the start of the study.
- Demonstrate normal cardiac function in response to exercise.
Exclusion Criteria
- Aged younger than 18, or older than 50 years.
- Suffering from, or diagnosed with a diabetes related complication (apart from mild background diabetic retinopathy).
- HbA1c >8.5%.
- Currently taking prescribed medication, and not currently treated with a stable basal bolus regimen composed of a combination glargine or determir, and lispro or aspart for at least 6 months before the start of the study.
- Failure to demonstrate normal cardiopulmonary responses during exercise, or have a medical condition which could prevent completion of exercise or be exacerbated because of.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Basal dose reduction Basal insulin dose Total daily basal (Glargine, Lantus, Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk) reduction of 20% versus normal basal dose.
- Primary Outcome Measures
Name Time Method 24 hour blood glucose area under the curve 24 hours 24 hour blood glucose area under the curve
- Secondary Outcome Measures
Name Time Method Ketonaemia 60 minutes before and 24 hours post-exercise Blood beta-hydroxybutyrate concentrations
Trial Locations
- Locations (1)
Clinical Research Facility, Royal Victoria Infirmary
🇬🇧Newcastle upon Tyne, Tyne and Wear, United Kingdom